Corneal Collagen Cross-Linking for Ectasia (CXL)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Avedro, Inc.
ClinicalTrials.gov Identifier:
NCT00674661
First received: May 6, 2008
Last updated: January 24, 2014
Last verified: January 2014
  Purpose

Prospective, randomized multicenter study to determine the safety and effectiveness of performing corneal collagen cross-linking (CXL) using riboflavin and UVA light in eyes with ectasia after refractive surgery.


Condition Intervention Phase
Ectasia
Drug: riboflavin ophthalmic solution
Device: UVA Irradiation
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Effectiveness of the UV-X System for Corneal Collagen Cross-Linking in Eyes With Corneal Ectasia After Refractive Surgery

Resource links provided by NLM:


Further study details as provided by Avedro, Inc.:

Primary Outcome Measures:
  • Change in keratometry [ Time Frame: 3 and 12 months ] [ Designated as safety issue: No ]

Enrollment: 179
Study Start Date: December 2007
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Corneal Collagen Cross-linking (CXL) Treatment Group
riboflavin ophthalmic solution and UVA irradiation
Drug: riboflavin ophthalmic solution
riboflavin 0.1% ophthalmic solution (approximately 32 drops, or 1.6 mL)
Device: UVA Irradiation
UVA light (365 nm at an irradiance of 3 mW/cm2) for 30 minutes
Other Name: UV-X™ Illumination System
Sham Comparator: Control Group
riboflavin opthalmic solution without UVA irradiation
Drug: riboflavin ophthalmic solution
riboflavin 0.1% ophthalmic solution (approximately 32 drops, or 1.6 mL)

Detailed Description:

Subjects are randomized to a control group or a treatment group, with the control group crossed over to the treatment group at the 3 month visit. Corneal collagen cross-linking is performed as a single treatment. Subjects are followed for 12 months after the procedure to evaluate the long term effects of corneal collagen cross-linking.

  Eligibility

Ages Eligible for Study:   14 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of ectasia after refractive surgery
  • Documented ectasia on Pentacam or topography map
  • BSCVA worse than 20/20
  • Must complete all study visits

Exclusion Criteria:

  • History of delayed wound healing
  • History of corneal melt or corneal dystrophy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00674661

Locations
United States, California
Shiley Eye Center
La Jolla, California, United States, 92093
Gordon -Weiss Vision Institute
San Diego, California, United States, 91222
United States, Florida
Center for Excellence in Eye Care
Miami, Florida, United States, 33176
United States, Indiana
Price Vision Group
Indianapolis, Indiana, United States, 46260
United States, Kansas
Durrie Vision
Overton (Kansas City), Kansas, United States, 66211
United States, Maryland
Wilmer Eye Institute at Johns Hopkins University
Baltimore, Maryland, United States, 21287
United States, Minnesota
Minnesota Eye Consultants
Minneapolis, Minnesota, United States, 55404
United States, New Jersey
Cornea & Laser Eye Institute; Hersh Vision Group
Teaneck, New Jersey, United States, 07666
United States, New York
Edward Harkness Eye Institute at Columbia University Medical Center
New York, New York, United States, 10032
Ophthalmic Consultants of Long Island
Rockville Centre, New York, United States, 11570
Sponsors and Collaborators
Avedro, Inc.
Investigators
Principal Investigator: Peter Hersh, MD Cornea and Laser Eye Institute
  More Information

No publications provided by Avedro, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Avedro, Inc.
ClinicalTrials.gov Identifier: NCT00674661     History of Changes
Other Study ID Numbers: UVX-003
Study First Received: May 6, 2008
Last Updated: January 24, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Avedro, Inc.:
ectasia
cross-linking
crosslinking
cornea
riboflavin
UVA

Additional relevant MeSH terms:
Dilatation, Pathologic
Pathological Conditions, Anatomical
Ophthalmic Solutions
Riboflavin
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Photosensitizing Agents
Dermatologic Agents
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on August 26, 2014